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FDA 510(k)

18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II

K-Number: K073559 · 2008-01-31

ApplicantEdwards Lifesciences Research Medical
Decision Date2008-01-31
Product CodeDQR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences Research Medical. It received FDA 510(k) clearance on 2008-01-31 under 510(k) number K073559. The device is classified under product code DQR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II?

18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II is a medical device that received FDA 510(k) clearance on 2008-01-31. The listed applicant is Edwards Lifesciences Research Medical. The 510(k) number is K073559.

When did 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II receive FDA 510(k) clearance?

18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II received FDA 510(k) clearance on 2008-01-31, under 510(k) number K073559.

Who is the listed applicant for 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II?

The FDA 510(k) record lists Edwards Lifesciences Research Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II?

The FDA product code for 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II is DQR.

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Other records listing Edwards Lifesciences Research Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESHK990396T-ANASTAFLOK991170RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014K983791PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULAK974259VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE

Related Devices (Code: DQR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131446INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESIntegra LifeSciences CorporationK051655ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.K030398CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221Cardiacassist, Inc.K960098RMI INTERNAL MAMMARY ARTERY CANNULAResearch Medical, Inc.K902674DATASCOPE ARTERIAL CANNULA W/ACCESS PORTDatascope Corp.K894784MODIFIED SHILEY FEMORAL VENOUS CANNULAShiley, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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